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Open, Classified

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007

FDA Recall Z-0071-2027 · Posted 2026-10-02

Recalling FirmSteris Corporation
Recall StatusOpen, Classified
Product CodeFRC
Date Initiated2026-08-31
Product Quantity409

Reason for Recall

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction

Firm Action

Firm began notifying customers on August 31, 2026 via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to destroy any affected product on hand. The firm will replace any product still within its shelf life.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854902SURGICOT STEAM TEST PACKSurgicot, Inc. · 1986-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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